ARCHIVED 1. List of Non-prescription Drugs for Which the Testing Requirements Set Out in Subsections C.02.019 (1) and (2) of the Food and Drug Regulations Do Not Apply
The solidus (/) in Column 6 indicates that the terms and/or the statements are synonymous. Either term or statement may be included on the label by the market authorization holder. Text in parentheses in column 6 is additional optional information which can also be added to the label at the market authorization holder's discretion.
| Column 1 | Column 2 | Column 3 | Column 4 | Column 5 | Column 6 | Column 7 |
|---|---|---|---|---|---|---|
| Class of Non-prescription Drugs | Active Ingredient(s) | Quantity of Active Ingredient(s) | Qualifier(s) | Route(s) of Administration | Permissible Use(s) or Purpose(s) | Last Revised (YYYY-MM-DD) |
| Mouthwashes | Cetylpyridinium Chloride | 0.05-0.075% | For human use | Dental, Gingival, Periodontal |
|
2020-03-13 |
| Personal Care Use Antiseptic Skin Cleansers | Benzalkonium chloride | 0.1-0.15% | For human use | Topical |
|
2020-03-13 |
| Benzethonium chloride | 0.05-0.5% | |||||
| Chlorhexidine gluconate | 2-4% | |||||
| Chloroxylenol | 0.5-3% | |||||
| Triclosan | 0.1-1% | |||||
| Sunscreens | Avobenzone | ≤3% | For human use The Sun Protection Factor (SPF) must be ≥2 and values greater than 50 must be declared as SPF 50+ |
Topical |
|
2020-03-13 |
| Bemotrizinol | ≤6% | |||||
| Oxybenzone | ≤6% | |||||
| Sulisobenzone | ≤10% | |||||
| Dioxybenzone | ≤3% | |||||
| Bisoctrizole | ≤5% | |||||
| Cinoxate | ≤3% | |||||
| Diethanolamine methoxycinnamate | ≤10% | |||||
| Drometrizole trisiloxane | ≤15% | |||||
| Ecamsule | ≤10% | |||||
| Ensulizole | ≤4% | |||||
| Enzacamene | ≤4% | |||||
| Homosalate | ≤15% | |||||
| Meradimate | ≤5% | |||||
| Octinoxate | ≤7.5% | |||||
| Octisalate | ≤5% | |||||
| Octocrylene | ≤10% | |||||
| Padimate O | ≤8% | |||||
| Trolamine salicylate | ≤12% | |||||
| Anti-Dandruff Products | Pyrithione zinc | 0.1-0.25% (Leave on) 0.3-2% (Rinse off) |
For human use | Topical |
|
2020-03-13 |
| Coal tar | 0.5-5% | |||||
| Coal tar + dl-Menthol / l-Menthol | 1.8% Coal tar + 1.5% dl-Menthol / l-Menthol (Rinse off) |
|||||
| Diaper Rash Products | Dimethicone | 1-30% | For human use | Topical |
|
2020-03-13 |
| Mineral oil | 50-100% | |||||
| Petrolatum | 30-100% | |||||
| White petrolatum | 30-100% | |||||
| Medicated Skin Care Products | Dimethicone | 1-30% | For human use | Topical |
|
2020-03-13 |
| Mineral oil | 50-100% | |||||
| Petrolatum | 30-100% | |||||
| White petrolatum | 30-100% | |||||
| Acne Therapy Products | Benzoyl peroxide | 2.5-5% | For human use | Topical |
|
2020-03-13 |
| Throat Lozenges | Dyclonine hydrochloride | 1 - 3 mg per lozenge | For human use | Oral |
|
2020-03-13 |
| Hexylresorcinol | 2 - 4 mg per lozenge | |||||
| Cetylpyridinium chloride | 1 - 2 mg per lozenge | |||||
| Dequalinium chloride | 0.25 mg per lozenge | |||||
| Domiphen bromide | 1.5 mg per lozenge | |||||
| Athletes Foot Products | Chlorphenesin | 0.5 - 1% | For human use | Topical |
|
2020-03-13 |
| Clioquinol | 3% | |||||
| Haloprogin | 1% | |||||
| Tolnaftate | 1% |
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